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Embolization Device Recall and Correction: Medtronic Removes Unused 027 Compatible Pipeline Vantage Embolization Device with Shield Technology, Updates Use Instructions for 021 Compatible Pipeline Vantage Embolization Devices due to Increased Risk of Incomplete Wall Apposition and Braid Deformation

Medtronic Neurovascular is recalling 027 Compatible Pipeline Vantage Embolization Devices and updating use instructions for 021 Compatible Pipeline Vantage Embolization Devices due to reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall (incomplete wall apposition and/or braid deformation) during and after procedures using these devices. Incomplete wall apposition and braid deformation, also sometimes called fish-mouthing, braid narrowing, or braid collapse, are known risks of these devices. The risks were higher in females, especially those younger than 45 years of age. 

The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves:

• removing the Pipeline Vantage 027 device models from where they are used or sold

• updating instructions for using the Pipeline Vantage 021 device models but not removing the 021 models from use.

The removed Pipeline Vantage 027 devices may cause serious injury or death if you continue to use them. The rates of serious injury or death reported at this time are lower in 021 devices compared to 027 devices; however, the updated instructions should be followed to further reduce the likelihood of observed complications.

Questions?

Customers in the U.S. with questions about this recall should contact their local Medtronic representative or Medtronic Quality Assurance at rs.nvquality@medtronic.com or 1-800-633-8766.